Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
L02BB04
ENZALUTAMIDE 40 mg
FILM-COATED TABLET
ENZALUTAMIDE 40 mg
POM
ENDOCRINE THERAPY
Authorised
2023-08-09
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Enzalutamide Sandoz 40 mg film-coated tablets Enzalutamide Sandoz 80 mg film-coated tablets enzalutamide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Enzalutamide Sandoz is and what it is used for 2. What you need to know before you take Enzalutamide Sandoz 3. How to take Enzalutamide Sandoz 4. Possible side effects 5. How to store Enzalutamide Sandoz 6. Contents of the pack and other information 1. WHAT ENZALUTAMIDE SANDOZ IS AND WHAT IT IS USED FOR Enzalutamide Sandoz contains the active substance enzalutamide. Enzalutamide Sandoz is used to treat adult men with prostate cancer that: - No longer responds to a hormone therapy or surgical treatment to lower testosterone Or - Has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone. HOW ENZALUTAMIDE SANDOZ WORKS Enzalutamide Sandoz is a medicine that works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENZALUTAMIDE SANDOZ DO NOT TAKE ENZALUTAMIDE SANDOZ - If you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6). - If you are pregnant or may become pregnant (see ‘Pregnancy, breast-feeding and fertility’) WARNINGS AND PRECAUTIONS Seizures Seizures were reported in 5 in every 1,000 people taking Enzalutamide Sandoz, and fewer than one in every Lue koko asiakirja
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Enzalutamide Sandoz 40 mg film-coated tablets Enzalutamide Sandoz 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Enzalutamide Sandoz 40 mg film-coated tablets Each film-coated tablet contains 40 mg of enzalutamide. Excipient(s) with known effect Each film-coated tablet contains 58 mg lactose (as monohydrate). Enzalutamide Sandoz 80 mg film-coated tablets Each film-coated tablet contains 80 mg of enzalutamide. Excipient(s) with known effect Each film-coated tablet contains 116 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Enzalutamide Sandoz 40 mg film-coated tablets Yellow, round, biconvex film-coated tablet debossed with “EN” on one side and “40” on the other side; diameter 10.5 – 11.3 mm. Enzalutamide Sandoz 80 mg film-coated tablets Yellow, oval, biconvex film-coated tablet debossed with “EN” on one side and “80” on the other side; length 16.9 – 17.7 mm; width 8.9 – 9.7 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Enzalutamide Sandoz is indicated for: • the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). • the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). • the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). • the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 2 Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. Posology The recommended dose is 160 mg enzalutamide (four 40 mg film-coated table Lue koko asiakirja